Kornimate/medical-research-clean huggingface dataset:
the effect of animated movies and storybooks on fear and anxiety levels in children with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Child, Only; Anxiety; Fear; Nurse

Summary: this study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

this study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. in the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. routine care will continue for the control group.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * parental approval * being between the ages of 7-12, * being diagnosed with t1d for the first time, * being literate and able to communicate in turkish exclusion criteria: * having a mental, visual, hearing or communication impairment, * having mental and spiritual health problems,
evaluation of the clinical benefit of a transmitter for contralateral routing of signals (cros)

Conditions: Hearing Loss

Summary: this study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. the benefit will be evaluated in noisy environments regarding speech intelligibility when the cros system is adjusted to different microphone settings. additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the cros system in combination with smartphone and accessories. this study is a confirmatory study.

unilateral hearing loss (uhl) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance. one solution for unaidable uhl is contralateral routing of signals (cros) and bilateral contralateral routing of signals (bicros) using a so- called cros transmitter together with a hearing aid. the rationale for this clinical investigation is to collect clinical data with a rechargeable cros transmitter to evaluate the benefits of a bicros fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Eligibility criteria:
inclusion criteria: * hearing impaired adults, with \& w/o hearing aids (experiences) * good written and spoken (swiss) german language skills * ability to fill in a questionnaire conscientiously * informed consent as documented by signature * asymmetric hearing loss: one unaidable ear (min. n6 hearing loss) / the other ear with n3 or n4 hearing loss * availability of smartphone * availability of tv or tablet * ability to operate and handle the investigational device * ability to describe listening impressions/experiences and the use of the hearing aid * ability to produce a reliable hearing test result exclusion criteria: * contraindications to the medical device: * aidable hearing loss on the intended cros side * acute tinnitus (in either one ear and occurrence less than three months) * anatomical deformity of the cros ear (e.g. absence of the auricle) * known hypersensitivity or allergy to materials of the investigational device * any auricle deformities, that prevents secure placement of the (test) devices * no willingness to test the investigational device system * no willingness to test the investigational device system for at least 8h a day * hint for psychological problems from investigators point of view * reported fluctuating hearing that could influence the test result * reported symptoms of vertigo and dizziness by participants
happy homes, healthy families: a relationship strengthening intervention for pregnant couples affected by hiv in zambia

Conditions: HIV Infections; Pregnancy Related

Summary: the objective of this study is to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with hiv in lusaka, zambia.

the central hypothesis of this study is that women living with hiv in heterosexual couples that have better relationship functioning and more social support will have greater odds of achieving optimal health during and after pregnancy. the study further hypothesizes that the couples-based intervention will improve interpersonal dynamics, such as communication, and in intrapersonal factors, such as women's mental health, which will mediate intervention effects on hiv care and treatment outcomes. the study will test the hypotheses through two specific aims: (1) compare service utilization and prevention of mother-to-child transmission (pmtct) outcome indicators in two study conditions; and (2) establish the effect of the intervention on intra- and inter-personal mechanisms influencing outcomes.

Eligibility criteria:
inclusion criteria: * heterosexual couple in a stable relationship (defined as sleeping under the same roof at least once a week) * relationship has lasted ≥ 6 months * both partners live in the clinic catchment area and plan to continue residing there for at least six months * both partners are at least 18 years of age * both partners willing to participate in the intervention * female partner is no more than 36 weeks pregnant * female partner is diagnosed as hiv-positive * severe intimate partner violence (world health organization definition) has not occurred within the couple in the past 6 months. exclusion criteria: * same-sex couple * couple who does not sleep under the same roof at least once a week * relationship has lasted \<6 months * one or both partners live outside the clinic catchment area * one or both partners plan to move outside the clinic catchment area * one or both partners are \<18 years of age * one or both partners unwilling to participate in the intervention * female partner is greater than 36 weeks pregnant * female partner is hiv-negative * severe intimate partner violence (world health organization definition) has occurred within the couple in the past 6 months.
cost-effectiveness of weight loss prevention in nursing homes: a controlled trial

Conditions: Weight Loss

Summary: low oral food and fluid intake and unintentional weight loss are common problems among long-stay nursing home (nh) residents and are associated with adverse, costly clinical outcomes. this study will use a controlled, intervention design to determine the cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition intervention that offers nh residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents across 4 nh sites. residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or (3) choice intervention. the usual care control group will continue to receive standard nh care for supplement or snack delivery. research staff will provide the same supplements used by the nh (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). thus, the labor costs of these interventions will be documented and compared to effectiveness measures. effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. these outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.


Eligibility criteria:
inclusion criteria: * long-stay nursing home residents, * capable of oral food and fluid intake, * physician or dietitian order for caloric supplementation. exclusion criteria: * short-stay nursing home residents (rehabilitation), * feeding tube, * hospice care.

Keywords: food and fluid intake nursing homes
the study of metastatic pancreatic adenocarcinoma

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: phase i part, primary objective: the maximum tolerated dose of s-1 in the slog regimen secondary objectives: the dose-limiting toxicity of the regimen phase ii part, primary objective: overall tumor response rate (by recist criteria) secondary objectives: disease control rate (objective response rate (orr) + stable disease ≧ 16 weeks), time to tumor progression, progression-free survival, overall survival ,safety profile, biomarker study

phase i: 2\~24 patients phase ii: considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage simon's design of 25 patients in the first stage and 27 patients in the second stage.

Eligibility criteria:
inclusion criteria: 1. patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mpac). 2. patients must have no history of prior chemotherapy. 3. patients with prior radiotherapy. 4. patients' baseline ecog performance status must be 2. 5. patients' life expectancy must be 12 weeks or greater. 6. patients' age must be 20 and 75. 7. patients must have adequate bone marrow function. 8. patients must have adequate liver and renal function. 9. all patients must be sign and give written informed consent. exclusion criteria: 1. patients who have major abdominal surgery, radiotherapy. 2. patients with central nervous system metastasis. 3. patients with active infection. 4. pregnant or breast-nursing women. 5. patients with active cardiopulmonary disease. 6. patients who have peripheral neuropathy \> grade i. 7. patients who have serious concomitant systemic disorders. 8. patients who have other prior or concurrent malignancy. 9. patients who are under biologic treatment for their malignancy.

Keywords: enroll the 80 patients in this trial
assessement of hepcidin in saliva in human volunteers

Conditions: Hepcidin, Saliva

Summary: iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. to diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. whole saliva is a potentially attractive fluid for disease biomarker discovery and diagnostic efforts, because it is readily available from most individuals, can be easily collected and the collection procedure is non-invasive. the iron storage protein ferritin is too big, to be secreted into saliva. however, the main iron regulatory protein hepcidin is a very small protein and there is some evidence for hepcidin detection in saliva. the production of serum hepcidin positively correlates with serum ferritin, thereby reflecting patient's iron status. whether hepcidin is detectable in saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs to be tested.


Eligibility criteria:
inclusion criteria: * normal-weight (bmi 18-24.9kg/m2) * fasting * participants need to have brushed their teeth at least 1 hour before the visit exclusion criteria: * acute, chronic illness * use of long-term medication other than contraception * medical problems known to affect fe homeostasis * smoking
effects of different kinds, different doses of 5-ht3 receptor antagonists on prevention of hypotension

Conditions: Hypotension; Shivering; Nausea and Vomiting; Vasopressor

Summary: the purpose of this study is to estimate effects of different kinds, different dose of 5-ht3 receptor antagonists on prevention of hypotension after spinal anesthesia


Eligibility criteria:
inclusion criteria: * patients undergoing spinal anesthesia exclusion criteria: * hypersensitivity on 5-ht3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Keywords: 5-ht3 receptor antagonist hypotension spinal anesthesia
a study to assess adverse events and change in disease state in adult participants being treated with humira in participants diagnosed with pyoderma gangrenosum (pg)

Conditions: Pyoderma Gangrenosum

Summary: pyoderma gangrenosum (pg) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. the main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (adr) of humira with pg participants. humira is the only drug approved for the treatment of pyoderma gangrenosum (pg) in japan. approximately 60 adult participants with pg at approximately 60 sites in japan. participants will receive injectable humira (adalimumab) as prescribed by the physician prior to enrolling in this study. there may be a higher burden for participants in this study compared to standard of care. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.


Eligibility criteria:
inclusion criteria: * diagnosed with pyoderma gangrenosum (pg). * have been prescribed humira for pg treatment within 14 days. exclusion criteria: - have pyoderma gangrenosum (pg) in previous treatment with humira.

Keywords: pyoderma gangrenosum humira adalimumab
xelox+bevacizumab followed by capecitabine+bevacizumab+radiotherapy as neoadjuvant treatment of locally advanced rectal adenocarcinoma

Conditions: Rectal Neoplasms; Locally Advanced Rectal Adenocarcinoma

Summary: the purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.


Eligibility criteria:
inclusion criteria: * written informed consent from patients who are able to understand the study request * histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; t3, operable t4 or txn+ * karnofsky ps index ≥ 70% * life expectancy \> 6 months * adequate bone marrow, liver and renal function: anc ≥ 1.5 x 10e9/l; platelets ≥ 100 x 10e9/l; hb ≥ 9g/dl; inr ≤ 1.5; bilirubin ≤ 1.5 x uln; alt and/or ast ≤ 2.5 x uln or ≤ 5 x uln (in case of hepatic metastasis); alkaline phosphatase ≤ 2.5 x uln or ≤ 5 x uln (in case of hepatic metastasis) or ≤ 10 x uln (in case of bone metastasis); creatinine clearance (cockcroft-gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x uln exclusion criteria: * distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry * surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study * previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, inr ≤ 1.5); chronic use of high-dose aspirin (\<325mg/day) or non-steroidal anti-inflammatory treatment * no integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs * pregnant or lactating patients; snc disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide saes or dpd deficiency
periscapular muscle activation during open and closed kinetic chain in stroke

Conditions: Hemiplegia

Summary: the goal of this observational study is to compare the activity levels of the periscapular (levator scapula, serratus anterior, infraspinatus, upper, middle and lower trapezius) muscles during open and closed kinetic chain activities in individuals with stroke. it is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. the main questions it aims to answer are: * the activation timing, percentage and viscoelastic properties of the periscapular muscles of stroke individuals compared to healthy individuals; * the activation timing and percentages of periscapular muscles during closed kinetic chain and open kinetic chain activities in stroke individuals; * the relationship between muscle activation timing, muscle activation percentage, viscoelastic properties, upper extremity motor performance and capacity. the study will include both hemiplegic (n=10) and healthy (n=10) participants. all of the participants will be assessed in terms of scapular muscle activation timing and percentage (with superficial electromyography) during both open kinetic chain and closed kinetic chain activities. viscoelastic properties of muscles (miyoton) will be evaluated. upper extremity movement frequency and quality (mag-28) and functional performance (fugl-meyer) will be evaluated to reveal the status of stroke individuals. in the study, it is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. 10 healthy and 10 hemiplegic individuals are planned to participate in the study.


Eligibility criteria:
inclusion criteria: stroke patients will be considered eligible for participation if they: * were at least 6 weeks after stroke (hemorrhagic or ischemic); * had mild to moderate upper limb motor impairment (score of ≥30 on the fugl-meyer upper limb motor part; * had a negative neer impingement test; * could sit or stand up independently at least 10 minutes. healthy controls will be considered eligible for participation if they: * had no self-reported shoulder pain; * had a negative neer impingement test. exclusion criteria: participants will be excluded according to these criteria: * being involuntary to participate and unable to follow the instructions; * being younger than 18 years old; * body mass index equal or higher than 30; * shoulder and/or neck pain in the last six months; * known history of shoulder dislocation, fracture or surgery; * other systemic and/or neurologic diseases. -

Keywords: hemiplegia scapular muscles muscle timing muscle activation kinetic chain
respiratory function, exercise capacity and peripheral muscle strength among patients with cf, pcd and healthy children

Conditions: Primary Ciliary Dyskinesia; Cystic Fibrosis

Summary: the aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with cf, pcd and healthy childrens.

the impaired airway clearence and pulmonary functions, exercise intolerance, low physical activity level and decreased peripheral muscle strength make physiotherapy approaches important in the management of cf and pcd.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis or primary ciliary dyskinesia exclusion criteria: * hospitalization history in past month * diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease * candidates for lung transplantation or history of lung transplantation

Keywords: respiratory functions exercise capacity muscle strength
the mobile health platform

Conditions: Obesity; Hypertension; Diabetes

Summary: this study develops and pilots the initial interface of our mobile health platform that will allow for intra-individual tailoring and personalization of health interventions. this will allow for just-in-time interventions that adapt both the content and timing, not just initially, but also over time based upon prior outcome data, responses to an intervention, current environmental and social context, activity level, location, time, and an individual's psychophysiological state.1,2 aim 1: to develop the initial interface of the mobile health platform that will allow patients to report and receive data representing multiple health domains including blood pressure, po2 (pulse oximeter), values, weight, physical activity, calories burned, sleep, and self-report survey measures such as pain and fatigue. aim 2: to assess feasibility of the mobile health platform to receive and deliver data representing multiple health domains over 1 month through a single-case study design (n=6).3 aim 3: to develop an algorithm using the diet data collected in aim 1 that will facilitate adaptive work by providing patients with automated real time feedback on their progress. aim 4: to develop an algorithm using the diet data collected in aim 1 that will that will facilitate adaptive approaches by alerting clinicians on the progress of their patients.

at baseline we will collect demographic variables and acceptance and use of technology from surveys, and biological variables including blood pressure, weight, and blood glucose from electronic medical records. over a period of 1 month, participants will be asked to track and collect daily data on weight using the ihealth wireless scale. participants will also collect blood pressure (bp), po2, and pulse using the ihealth blood pressure device. physical activity and sleep activity will be measured using the fitbit device. participants will receive evidence-based daily nutrition and exercise weight loss messages via text messages. following the one-month observation participants will be asked to complete a follow-up survey on acceptance and use of technology and to undergo a post-formative semi-structure telephone interview to discuss their perception of the usefulness and attitudes toward the platform, technical difficulties and barriers, and recommendations for future development.

Eligibility criteria:
inclusion criteria: * patient of picket primary care clinic * all subjects will provide written informed consent. * three participants who have multiple chronic illnesses. * chronic illnesses of obesity (bmi\>29) * chronic hypertension (sbp\>140) * three healthy participants who do not have any chronic illnesses. * own a smartphone with a data and text messaging plan. * have wifi available in the home. exclusion criteria: * no internet/wifi available in the home. * no smartphone

Keywords: mobile technology chronic illness wireless blood pressure device wireless scale pedometer